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Accurate Clinical Study of Medication in Patients With Depression Via Pharmacogenomics (PGx) and Therapeutic Drug Monitoring (TDM) of Venlafaxine

Primary Purpose

Depression

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

pharmacogenomics

pharmacogenomics & therapeutic drug monitoring

Venlafaxine

About this trial

This is an interventional treatment trial for Depression focused on measuring pharmacogenomics, PGx, therapeutic drug monitoring, TDM, Venlafaxine, depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with endogenous depression, with any of the following 4 symptoms: ① Interest Loss; ② Hypothymia; ③ Early awakening; ④ Serious in the morning and relieved at night; ⑤ Hysteresis or agitation of movement of Spirit; ⑥ Appetite loss; ⑦ Weight loss; ⑧ Loss of libido;
Scores of 17 items in Hamilton Depression Scale (HAM-D17): over 17 points;
First-episode patients or relapsed patients without taking any antidepressant drugs in the recent 3 months;
No significant abnormalities are shown in physical examination (temperature, pulse, blood pressure, head and neck, chest and abdomen).
No obvious abnormalities in laboratory examination (Thyroid Function).
Informed patient consent.

Exclusion Criteria:

Those diagnosed with mental disorders other than major depressive disorders (with the exception of combination of anxiety disorders); non-endogenous depressive disorders;
Patients with stroke, brain tumor and other brain organic diseases;
Patients receiving combined drugs (but there is no need to exclude patients receving drugs against sleep disorders, such as Eszopiclone, alprazolam or estazolam);
History of drug allergy;
Pregnant and lying-in women;
Patients with serious suicidal tendencies.

Sites / Locations

Xijing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

A group: Routine treatment group

B group: PGx-guided group

C group: Routine PGx-guided group

D group: The combination of PGx and TDM group

Arm Description

Routine dosage of venlafaxine during the first 4 weeks.

The PGx test results guide the dosage of venlafaxine during the first 4 weeks.

The PGx test results guide the dosage of venlafaxine between 4th and 8th weeks.

The PGx and TDM test results guide the dosage of venlafaxine between 4th and 8th weeks.

Outcomes

Primary Outcome Measures

Score reduction rate of Hamilton Depression Rating Scale

Reduction Rate=[(total score before treatment-total score after treatment)/total score before treatment] *100% Healed: reduction rate ≥ 75%; Significant Effective: reduction rate≥50％and <75％; ③Effective: reduction rate≥25％ and <50％; ④Invalid: Reduction rate < 25%

Secondary Outcome Measures

Full Information

NCT ID

NCT04207385

First Posted

December 18, 2019

Last Updated

December 19, 2019

Sponsor

Xijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04207385

Brief Title

Accurate Clinical Study of Medication in Patients With Depression Via Pharmacogenomics (PGx) and Therapeutic Drug Monitoring (TDM) of Venlafaxine

Official Title

Accurate Clinical Study of Medication in Patients With Depression Via Pharmacogenomics (PGx) and Therapeutic Drug Monitoring (TDM) of Venlafaxine

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2019 (Actual)

Primary Completion Date

August 31, 2021 (Anticipated)

Study Completion Date

November 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study evaluates the efficacy of PGx-guided medication in patients with depression treated with Venlafaxine and the efficacy of the combination of PGx and TDM in patients with depression treated with Venlafaxine. Half of participants will receive PGx-guided treatment, while the other half will receive routine treatment. After the 8th week, the PGx-guided treatment group would be randomly divided into two groups. Of which, half of participants will receive the combination of PGx and TDM, and the other half will receive PGx -guided medication only.

Detailed Description

The current clinical medication is based on "Trial and Error", while the traditional medication is mainly based on experience. The study mainly optimizes the treatment path from two perspectives: to help clinicians select drugs accurately through the detection of PGx; to help clinicians monitor the whole process of drug use through TDM and adjust the dosage in time to achieve better treatment. PGx tests take the information of metabolic, transporting and target genetic factors into account comprehensively. Furthermore, clinical effects depend on blood concentration rather than dose concentration. TDM aims to monitor blood concentration, which is related to drug efficacy and toxicity. Venlafaxine is an antidepressant drugs of the 5-hydroxytryptamine selective seratonin re-uptake inhibitors (SSRIs), which has been approved by FDA for the treatment of depressive disorders, depressive disorders with anxiety symptoms, generalized anxiety disorders and social anxiety disorders since 1994.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

pharmacogenomics, PGx, therapeutic drug monitoring, TDM, Venlafaxine, depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

A group: Routine treatment group

Arm Type

Active Comparator

Arm Description

Routine dosage of venlafaxine during the first 4 weeks.

Arm Title

B group: PGx-guided group

Arm Type

Experimental

Arm Description

The PGx test results guide the dosage of venlafaxine during the first 4 weeks.

Arm Title

C group: Routine PGx-guided group

Arm Type

Active Comparator

Arm Description

The PGx test results guide the dosage of venlafaxine between 4th and 8th weeks.

Arm Title

D group: The combination of PGx and TDM group

Arm Type

Active Comparator

Arm Description

The PGx and TDM test results guide the dosage of venlafaxine between 4th and 8th weeks.

Intervention Type

Diagnostic Test

Intervention Name(s)

pharmacogenomics

Intervention Description

pharmacogenomics

Intervention Type

Diagnostic Test

Intervention Name(s)

pharmacogenomics & therapeutic drug monitoring

Intervention Description

pharmacogenomics & therapeutic drug monitoring

Intervention Type

Drug

Intervention Name(s)

Venlafaxine

Intervention Description

Venlafaxine hydrochloride sustained-release capsules 75mg x 14 tablets x 1 case 75-225mg/morning

Primary Outcome Measure Information:

Title

Score reduction rate of Hamilton Depression Rating Scale

Description

Time Frame

3 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with endogenous depression, with any of the following 4 symptoms: ① Interest Loss; ② Hypothymia; ③ Early awakening; ④ Serious in the morning and relieved at night; ⑤ Hysteresis or agitation of movement of Spirit; ⑥ Appetite loss; ⑦ Weight loss; ⑧ Loss of libido; Scores of 17 items in Hamilton Depression Scale (HAM-D17): over 17 points; First-episode patients or relapsed patients without taking any antidepressant drugs in the recent 3 months; No significant abnormalities are shown in physical examination (temperature, pulse, blood pressure, head and neck, chest and abdomen). No obvious abnormalities in laboratory examination (Thyroid Function). Informed patient consent. Exclusion Criteria: Those diagnosed with mental disorders other than major depressive disorders (with the exception of combination of anxiety disorders); non-endogenous depressive disorders; Patients with stroke, brain tumor and other brain organic diseases; Patients receiving combined drugs (but there is no need to exclude patients receving drugs against sleep disorders, such as Eszopiclone, alprazolam or estazolam); History of drug allergy; Pregnant and lying-in women; Patients with serious suicidal tendencies.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Huaning Wang

Phone

+86 13609161341

xskzhu@fmmu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huaning Wang

Organizational Affiliation

Deputy Chief Physician

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ping Zhou

Organizational Affiliation

Attending Physician

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yihuan Chen

Organizational Affiliation

Attending Physician

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Huizhen Lu

Organizational Affiliation

Resident Physician

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Qinghong Yan

Organizational Affiliation

Nurse

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xijing Hospital

City

Xi'an

State/Province

Shanxi

ZIP/Postal Code

710032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Huaning Wang

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Accurate Clinical Study of Medication in Patients With Depression Via Pharmacogenomics (PGx) and Therapeutic Drug Monitoring (TDM) of Venlafaxine

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